IceCure Medical (NasdaqCM:ICCM) Update / Briefing Transcript

Summary of IceCure Medical's Conference Call Company and Industry - Company: IceCure Medical Ltd - Industry: Medical Devices, specifically focused on breast cancer treatment Core Points and Arguments 1. FDA Marketing Authorization: IceCure Medical received FDA marketing authorization for the ProSense cryoablation system for local treatment of low-risk breast cancer in women aged 70 and above when combined with endocrine therapy [2][6] 2. Target Population: The approved indication covers approximately 46,000 women in the U.S. annually, specifically those with biologically low-risk tumors up to 1.5 centimeters who are not suitable for surgery [6][7] 3. Innovative Treatment: ProSense is the first and only medical device approved for breast cancer treatment that offers a minimally invasive outpatient procedure, which destroys tumors by freezing without removing breast tissue [7][8] 4. Clinical Validation: The FDA's decision was supported by data from the ICE3 study, showing outcomes comparable to traditional lumpectomy without surgery [7][10] 5. Market Positioning: The marketing authorization positions ProSense to set a new standard of care for eligible patient populations in the U.S. and reflects IceCure's commitment to improving women's quality of life globally [3][8] 6. Reimbursement Strategy: Procedures conducted through the post-market study will be eligible for CPT III reimbursement, which covers $3,800 of facility costs, potentially accelerating adoption across the U.S. [10][4] 7. Global Expansion: The FDA authorization is expected to have a global impact, facilitating regulatory submissions in other countries, including Japan and the European Union [11][12] Additional Important Content 1. Post-Market Surveillance Study: IceCure plans to conduct a post-market study involving approximately 400 patients across 30 sites, which will also serve as commercial sites for treatment [10][17] 2. Future Capital Needs: The company successfully raised $10 million in a rights offering to fund short-term commercialization and the post-market study [31] 3. Go-to-Market Strategy: IceCure's strategy includes expanding the U.S. sales team in 2026 and engaging with professional medical societies to ensure cryoablation is included in treatment guidelines [9][34] 4. Potential for Off-Label Use: Physicians may treat patients under 70 as off-label, particularly those who are non-candidates for surgery due to comorbidities [36][37] 5. Upcoming Events: The CFO will meet investors in Los Angeles and attend the Maxim Growth Conference in New York City later in October [39]